Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000947505
Ethics application status
Approved
Date submitted
19/08/2015
Date registered
9/09/2015
Date last updated
13/12/2019
Date data sharing statement initially provided
13/12/2019
Date results information initially provided
13/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving access to mental health services for children with anxiety.
Scientific title
Cool Kids Online compared to waitlist for the remission of anxiety disorders in clinically anxious children.
Secondary ID [1] 287316 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 295953 0
Condition category
Condition code
Mental Health 296226 296226 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition 1 (Cool Kids Online): 8 interactive online lessons over 10 weeks with weekly brief therapist phone contact and automated emails.

Condition 2 (Waitlist Control): 10 week wait (no contact).

Cool Kids Online is a skills based, cognitive-behavioural treatment (CBT) program delivered over the internet. The CBT lessons include psychoeducation about anxiety and skills to manage anxiety. Skills focus on thinking styles and behavioural responses to anxiety.

Lessons are completed by both parent (coach) and child together. In addition, each lesson has extra information especially for parents. This extra information teaches parents helpful strategies to respond to anxiety and assist their child to implement the Cool Kids online skills.

Cool Kids Online material is presented using animated video and audio material, case examples and practice activities/information handouts. Lessons focus on specific skills that build sequentially from the previous lessons. Each lesson takes approximately 60 minutes (45 for parent and child together, 15 minutes for parents alone).

Parents will receive brief (approx. 15 min) phone-calls from a therapist after completing each lesson and will receive brief, system-generated, emails focused on consolidating learning.

Participants in the waitlist condition will not receive contact or treatment for 10 weeks. They will subsequently be offered the Cool Kids Online program as described above.
Intervention code [1] 292636 0
Treatment: Other
Intervention code [2] 292736 0
Behaviour
Comparator / control treatment
The comparator group involves no treatment.
Participants in the waitlist condition will not receive contact or treatment for 10 weeks. They will subsequently be offered the Cool Kids Online program as described above.
Control group
Active

Outcomes
Primary outcome [1] 295890 0
% of participants with remission of primary anxiety diagnosis via the ADIS-IV C/P amended for DSM-5
Timepoint [1] 295890 0
Post-Baseline (10 weeks after baseline) and 6 months post-treatment.
Secondary outcome [1] 316858 0
% of participants with remission of any anxiety diagnosis via the ADIS-IV C/P amended for DSM-5
Timepoint [1] 316858 0
Post-Baseline (10 weeks after baseline) and 6 months following treatment
Secondary outcome [2] 316859 0
Change on CGI
Timepoint [2] 316859 0
Post-Baseline (10 weeks post baseline) and 6 months post-treatment
Secondary outcome [3] 316860 0
Change in Clinician Severity Ratings
Timepoint [3] 316860 0
Post-Baseline (10 weeks post baseline) and 6 months post-treatment
Secondary outcome [4] 316861 0
Change on parent-report Spence Children's Anxiety Scale (Spence, 1998)
Timepoint [4] 316861 0
Post-Baseline (10 weeks post baseline) and 6 months post-treatment
Secondary outcome [5] 316862 0
Change on parent-report Short Mood and Feeling Questionnaire (Angold et al 1995)
Timepoint [5] 316862 0
Post-Baseline (10 weeks post baseline) and 6 months post-treatment
Secondary outcome [6] 316863 0
Change on parent-report Strengths and Difficulties Questionnaire (Goodman, 1997)
Timepoint [6] 316863 0
Post-Baseline (10 weeks post baseline) and 6 months post-treatment
Secondary outcome [7] 316864 0
Change on parent-report Child Anxiety Life Interference Scale (CALIS; Lyneham et al 2013
Timepoint [7] 316864 0
Post-Baseline (10 weeks post baseline) and 6 months post-treatment
Secondary outcome [8] 316865 0
Change on parent-report Paediatric Quality of Life Inventory (Varni et al 2001)
Timepoint [8] 316865 0
Post-Baseline (10 weeks post baseline) and 6 months post-treatment
Secondary outcome [9] 316866 0
Change on child-report Spence Children's Anxiety Scale (Spence 1998)
Timepoint [9] 316866 0
Post-Baseline (10 weeks post baseline) and 6 months post-treatment
Secondary outcome [10] 316867 0
Change on child report Short Mood and Feelings Questionnaire (Angold et al 1995)
Timepoint [10] 316867 0
Post-Baseline (10 weeks post baseline) and 6 months post-treatment
Secondary outcome [11] 316868 0
Change on child report Strengths and Difficulties Questionnaire (Goodman, 1997)
Timepoint [11] 316868 0
Post-Baseline (10 weeks post baseline) and 6 months post-treatment
Secondary outcome [12] 316869 0
Change on child report Child Anxiety Life Interference Scale (CALIS, Lyneham et al 2013)
Timepoint [12] 316869 0
Post-Baseline (10 weeks post baseline) and 6 months post-treatment
Secondary outcome [13] 316870 0
Change on child-report Paediatric Quality of Life Inventory (Varni et al. 2001)
Timepoint [13] 316870 0
Post-Baseline (10 weeks post baseline) and 6 months post-treatment

Eligibility
Key inclusion criteria
Primary Anxiety Diagnosis
Minimum age
7 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Accessing other psychological treatment
- Non-stable medication treatment
- Significant learning delays or developmental disorders
- Autism or a related disorder
- Significant unmanaged behavioural disorder
- Unmanaged psychotic symptoms
- Is considered at risk due to abuse, neglect, suicidality/self-harm, or extended school refusal.
- Parents are not proficient reading English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants self-refer to the research team, are sent information about the research trial. They provide brief information to screen for inclusion, and if suitable are booked in for a diagnostic assessment (telephone interview with parent and child, and online questionnaires). If the program is suitable, participants provide consent for treatment and are randomised into either of two conditions (waitlist or Cool Kids Online treatment). Randomisation list is help by an investigator who is not involved in the assessment or treatment of clients. Randomisation order will be generator by computer system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sealed Envelope Ltd. 2015 will be used to generate the randomisation list. The same randomisation sequence will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The study is parallel in that participants will be randomly allocated (initially) to Cool Kids Online or 10-week delayed access to Cool Kids Online. Participants allocated to the delayed treatment start will be subsequently given access to the program. All participants will be assessed 6 months after completing treatment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be conducted using intention-to-treat and completer
models. Multiple imputation will be used to impute missing data.
Categorical data will be analysed via chi-squared tests, and continuous data with parametric or equivalent non-parametric tests including mixed linear models.
Sample of 100 will allow power of .93 to detect medium to large effects between groups. Allowing 10% dropout, a sample of N = 90 will allow power of .90 to detect the same medium to large effects.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
19/08/2015
Actual
27/08/2015
Date of last participant enrolment
Anticipated
28/04/2017
Actual
28/02/2017
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
100
Accrual to date
Final
95
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 291880 0
Charities/Societies/Foundations
Name [1] 291880 0
Australian Rotary Health
Country [1] 291880 0
Australia
Primary sponsor type
Individual
Name
Lauren McLellan
Address
Department of Psychology
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 290545 0
None
Name [1] 290545 0
Address [1] 290545 0
Country [1] 290545 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293389 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 293389 0
Level 3, Research HUB, C5C,
Macquarie University
NSW 2109
Ethics committee country [1] 293389 0
Australia
Date submitted for ethics approval [1] 293389 0
Approval date [1] 293389 0
26/05/2015
Ethics approval number [1] 293389 0
5201500237

Summary
Brief summary
Anxiety disorders are the most common mental disorder in children with 1 in 5 experiencing an anxiety disorder before adulthood. The Centre for Emotional Health at Macquarie University has developed a program, Cool Kids, which is effective in treating these disorders. Improving access to care is an essential next-step in the dissemination of effective treatments for anxiety disorders – particularly in Australia, given the vast regional and remote areas. We will conduct a randomized clinical trial comparing treatment to waitlist conditions to evaluate the efficacy of the Cool Kids program delivered online for the treatment of anxiety disorders in young people. The project hypotheses are as follows:
1) the Cool Kids Online program will produce significantly better outcomes than waitlist control (no treatment) on anxiety diagnoses, symptoms and life interference,
2) treatment gains following the Cool Kids Online program will be maintained over a six month follow-up period, and
3) families completing the Cool Kids Online program will report high levels of treatment satisfaction.
Trial website
http://centreforemotionalhealth.com.au/pages/coolkidsonline.aspx
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59666 0
Dr Lauren McLellan
Address 59666 0
Department of Psychology
Macquarie University NSW 2109
Country 59666 0
Australia
Phone 59666 0
+61(2)9850 1463
Fax 59666 0
Email 59666 0
[email protected]
Contact person for public queries
Name 59667 0
Dr Lauren McLellan
Address 59667 0
Department of Psychology
Macquarie University NSW 2109
Country 59667 0
Australia
Phone 59667 0
+61(2) 9850 1463
Fax 59667 0
Email 59667 0
[email protected]
Contact person for scientific queries
Name 59668 0
Dr Lauren McLellan
Address 59668 0
Department of Psychology
Macquarie University NSW 2109
Country 59668 0
Australia
Phone 59668 0
+61(2)9850 1463
Fax 59668 0
Email 59668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.